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- Tasks: Ensure medical devices meet regulatory standards and support product development.
- Company: Join JointMedica, a leader in innovative orthopaedic device manufacturing.
- Benefits: Enjoy opportunities for growth, collaboration, and impactful work in healthcare.
- Why this job: Make a difference in patient care while working in a dynamic, supportive environment.
- Qualifications: Bachelor's in biomedical engineering or life sciences; strong regulatory knowledge required.
- Other info: Experience with hip resurfacing devices is a plus; remote work options may be available.
The predicted salary is between 36000 - 60000 £ per year.
JointMedica is a growing company in the medical device sector that designs and manufactures several implantable orthopaedic devices and their associated surgical instruments. About the Role The Regulatory Associate role is critical in ensuring that the company\’s medical devices meet all necessary regulatory and quality standards while supporting the development and commercialization of hip resurfacing and total hip arthroplasty implants. Reporting to the VP of Quality Assurance and Regulatory Affairs, this position is responsible for regulatory compliance, regulatory strategy, and engagement with regulatory bodies globally. This position offers a unique opportunity to impact the development and compliance of innovative orthopaedic devices, with a focus on regulatory excellence and quality assurance leadership. The primary responsibilities include: Regulatory Compliance : Ensure compliance with FDA, ISO (e.g., ISO 13485), and other international regulations; develop and oversee internal systems to meet regulatory requirements. Regulatory Strategy Development : Create and align regulatory strategies with commercial goals for market entry, prioritizing key clearances as per the Global Regulatory plan. Submission Preparation : Manage projects related to new product introductions, prepare technical files and design dossiers for submissions, and support regulatory applications like 510(k), PMA, and IDEs. Regulatory Intelligence & Liaison : Stay updated on regulatory trends, serve as the main contact for agencies, and manage communications and audits. Risk Management & Compliance Audits : Contribute to risk mitigation programs and participate in compliance audits. Post-Market Surveillance & Clinical Integration : Support clinical surveillance, generate evaluation reports, and assist in updating surgical techniques based on clinical data. Design and Development Input : Use clinical insights to guide design refinements and maintain design history files. Requirements Required skills and qualifications: Bachelor\’s degree in biomedical engineering, life sciences, or relevant experience. Strong knowledge of FDA regulations (21 CFR 820), ISO standards, and international regulations. Proficiency in regulatory submissions including 510(k), PMA, and Technical Files. Analytical problem-solving and decision-making skills. Proficiency with database management and QA tools. Excellent communication skills for internal and external interactions. Understanding of medical device industry trends and technologies. Experience with hip resurfacing or total hip arthroplasty devices is advantageous. Ability to manage regulatory processes from development to post-market. Experience collaborating with external consultants and regulators for global market entry. #J-18808-Ljbffr
Regulatory Associate employer: Jointmedica Ltd
Contact Detail:
Jointmedica Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Associate
✨Tip Number 1
Familiarise yourself with the specific regulatory frameworks relevant to the medical device sector, particularly FDA regulations and ISO standards. This knowledge will not only help you understand the role better but also demonstrate your commitment and expertise during interviews.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with orthopaedic devices. Attend industry conferences or webinars to connect with potential colleagues and learn about current trends and challenges in regulatory compliance.
✨Tip Number 3
Stay updated on recent changes in regulatory policies and guidelines by following relevant publications and regulatory agency announcements. Being well-informed will allow you to engage in meaningful discussions during interviews and showcase your proactive approach.
✨Tip Number 4
Prepare to discuss specific examples of how you've contributed to regulatory compliance or strategy in previous roles. Highlighting your hands-on experience with submissions like 510(k) or PMA will set you apart from other candidates and show your practical understanding of the role.
We think you need these skills to ace Regulatory Associate
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly understand the responsibilities and requirements of the Regulatory Associate position at JointMedica. Tailor your application to highlight how your skills and experiences align with their needs.
Highlight Relevant Experience: In your CV and cover letter, emphasise any experience you have with regulatory compliance, particularly with FDA regulations and ISO standards. Mention specific projects or roles where you managed regulatory submissions or worked with medical devices.
Showcase Analytical Skills: Since the role requires strong analytical problem-solving skills, provide examples in your application that demonstrate your ability to analyse complex information and make informed decisions, especially in a regulatory context.
Communicate Effectively: Excellent communication skills are crucial for this role. Ensure your application is well-written, clear, and concise. Use your cover letter to illustrate how you've successfully communicated with regulatory bodies or collaborated with teams in previous roles.
How to prepare for a job interview at Jointmedica Ltd
✨Know Your Regulations
Familiarise yourself with FDA regulations, ISO standards, and international guidelines relevant to the medical device sector. Be prepared to discuss how these regulations impact product development and compliance.
✨Showcase Your Analytical Skills
Prepare examples that demonstrate your analytical problem-solving abilities. Discuss specific instances where you've successfully navigated regulatory challenges or contributed to risk management strategies.
✨Communicate Effectively
Highlight your communication skills by preparing to explain complex regulatory concepts in simple terms. Practice articulating your thoughts clearly, as this role requires liaising with various stakeholders.
✨Stay Updated on Industry Trends
Research current trends in the medical device industry, especially related to hip resurfacing and total hip arthroplasty. Being knowledgeable about recent developments will show your passion for the field and readiness to contribute.
